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Viaskin Milk

Phase 2

Eosinophilic Esophagitis | Small molecule | Other |DBV Technologies S.A.|Last Updated: Jul 10, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02579876Milk Patch for Eosinophilic EsophagitisPHASE2 COMPLETED 20 — — Oct 1, 2015Nov 20, 2018Jul 10, 20191 United States
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Study Endpoints
Primary Endpoints
Change in Maximum Esophageal Eosinophil Count From Baseline to End of Double-blind Treatment. (Intent to Treat Population)
From baseline to month 11 (end of double blind phase)

Esophageal biopsy samples will be obtained prior to randomization and after completion of treatment. Intraepithelial eosinophils will be counted in all high powered fields (HPFs) using light microscopy. A HPF will be counted only if at least half of the field is occupied by tissue. The maximum eosinophil count per HPF will be reported for each esophageal biopsy site (at each of 2 levels). The maximum eosinophil count for each patient will be calculated from either level. For the final outcome, mean from each individual patients maximum eosinophil count/hpf along with standard deviation will be calculated.

Change in Eosinophils/High Power Field at End of Double-blind (DB) (Per Protocol Patients)
Month 11(end of double blind phase)

Esophageal biopsy samples will be obtained prior to randomization and after completion of treatment. Intraepithelial eosinophils will be counted in all high powered fields (HPFs) using light microscopy. A HPF will be counted only if at least half of the field is occupied by tissue. The maximum eosinophil count per HPF will be reported for each esophageal biopsy site (at each of 2 levels). The maximum eosinophil count for each patient will be calculated from either level. For the final outcome, mean from each individual patients maximum eosinophil count/hpf along with standard deviation will be calculated.

Secondary Endpoints
Eosinophilic Esophagitis Symptom Score (Intent to Treat Population)
Total Symptom Score at End of DB Phase, Month 11
Esophageal Endoscopy Score (ITT)
At end of DB phase, at 11 months
Eosinophils Per HPF at End of Double Bind Protocol (Per Protocol) Patients
End of DB Phase, at 11 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Viaskin Milk 500 mcgACTIVE_COMPARATORViaskin patch containing milk protein. The patch is applied to the skin
Viaskin PlaceboPLACEBO_COMPARATORViaksin patch without any milk protein.
Interventions
NameTypeDescription
Viaskin Milk 500 mcgDRUGBiological: Viaskin Milk 500 mcg Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Viaskin PlaceboDRUGBiological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
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Eligibility Criteria
Age Range4 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Well-documented medical history of Eosinophilic Esophagitis after ingestion of milk and currently following a strict milk-free diet. * Upper endoscopy and biopsy at initial clinical evaluation during Visit 2 showing greater than 15 eosinophils/high power field (HPF) isolated t...

Countries:United States
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Competitive Landscape -Eosinophilic Esophagitis 9 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN1PHASE3Tezepelumab
Regeneron Pharmaceuticals, Inc.REGN3PHASE3dupilumab, Dupilumab
Phathom Pharmaceuticals, Inc.PHAT1PHASE2Vonoprazan
Eupraxia Pharmaceuticals, Inc.EPRX1PHASE1EP-104GI
Sanofi SA Sponsored ADRSNY1 — Dupilumab
Smith & Nephew plc Sponsored ADRSNN1 — Undisclosed
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